Trial Outcomes & Findings for Fibre-optic Guided Tracheal Intubation Through SADs (NCT NCT03118596)

Results Overview

Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

180 participants

Primary outcome timeframe

less than 3 minutes

Results posted on

2020-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	I-gel Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Overall Study STARTED	90	90
Overall Study Treated	2	0
Overall Study Failed	0	4
Overall Study COMPLETED	90	86
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I-gel n=90 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=90 Participants	0 Participants n=86 Participants	0 Participants n=176 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=90 Participants	55 Participants n=86 Participants	112 Participants n=176 Participants
Age, Categorical >=65 years	33 Participants n=90 Participants	31 Participants n=86 Participants	64 Participants n=176 Participants
Age, Continuous	55.7 years STANDARD_DEVIATION 15 • n=90 Participants	54.7 years STANDARD_DEVIATION 17 • n=86 Participants	55 years STANDARD_DEVIATION 15 • n=176 Participants
Sex: Female, Male Female	39 Participants n=90 Participants	35 Participants n=86 Participants	74 Participants n=176 Participants
Sex: Female, Male Male	51 Participants n=90 Participants	51 Participants n=86 Participants	102 Participants n=176 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	90 participants n=90 Participants	86 participants n=86 Participants	176 participants n=176 Participants

PRIMARY outcome

Timeframe: less than 3 minutes

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Total Intubation Time to Perform Fibreoptic Intubation	54.3 seconds Standard Deviation 13.8	52.0 seconds Standard Deviation 13

SECONDARY outcome

Timeframe: less than 1 minute

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
SAD Insertion Time	19.4 seconds Standard Deviation 5.6	25.4 seconds Standard Deviation 7.9

SECONDARY outcome

Timeframe: less than 2 minutes

Number of attempts taken to successfully place the supraglottic airway device in the oropharynx

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: less than 2 minutes

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

The ease of placement of the SAD assessed by the investigator on a four point scale: 1. \- Easy 2. \- Moderate Difficulty 3- Severe Difficulty 4 - Failure

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Number of Participants With Ease of Placement of the SAD Easy	86 participants	37 participants
Number of Participants With Ease of Placement of the SAD Moderate Resistance	6 participants	44 participants
Number of Participants With Ease of Placement of the SAD Severe Resistance	0 participants	5 participants
Number of Participants With Ease of Placement of the SAD Failure	0 participants	0 participants

SECONDARY outcome

Timeframe: less than 3 minutes

Population: IIn 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Number of Participants With First and Second Attempt at Tracheal Intubation First Attempt	90 Participants	84 Participants
Number of Participants With First and Second Attempt at Tracheal Intubation Second Attempt	2 Participants	2 Participants

SECONDARY outcome

Timeframe: less than 3 minutes

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

The quality of the view of the vocal cords seen through the SAD. It will be assessed, according to the previously published system, as: grade I - full view of the vocal cord, II - partial view of the vocal cords including arytenoids, III - epiglottis only, IV - other (SAD cuff, pharynx, others)

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD Grade 1	71 Participants	72 Participants
Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD Grade 2	20 Participants	14 Participants
Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD Grade 3	1 Participants	0 Participants

SECONDARY outcome

Timeframe: less than 1 minute

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Time to Carinal View	23.4 seconds Standard Deviation 10	21.9 seconds Standard Deviation 8.3

SECONDARY outcome

Timeframe: less than 3 minutes

Population: In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

The number of tube rotations performed during tracheal intubation

Outcome measures

Outcome measures
Measure	I-gel n=92 Participants Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	LMA Protector n=86 Participants Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, Tube impingement (No)	54 Participants	63 Participants
Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, Tube impingement (Yes)	38 Participants	23 Participants

Adverse Events

I-gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LMA Protector

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Cyprian Mendonca

University Hospitals Coventry & Warwickshire NHS Trust

Phone: 02476964000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place